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FDA 510(k)

AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS

K-Number: K942158 · 1994-07-29

ApplicantWfr/Aquaplast Corp.
Decision Date1994-07-29
Product CodeEPP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS is the device name listed in this FDA 510(k) record. The listed applicant is Wfr/Aquaplast Corp.. It received FDA 510(k) clearance on 1994-07-29 under 510(k) number K942158. The device is classified under product code EPP. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS?

AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS is a medical device that received FDA 510(k) clearance on 1994-07-29. The listed applicant is Wfr/Aquaplast Corp.. The 510(k) number is K942158.

When did AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS receive FDA 510(k) clearance?

AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS received FDA 510(k) clearance on 1994-07-29, under 510(k) number K942158.

Who is the listed applicant for AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS?

The FDA 510(k) record lists Wfr/Aquaplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS?

The FDA product code for AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS is EPP.

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Other records listing Wfr/Aquaplast Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EPP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942724EXTERNAL NASAL SPLINTMicromed Development Corp.K895502MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINTMicrobio-Medics, Inc.K890599HOOD NASAL SPLINTHood LaboratoriesK882244RICHARDS THERMOPLASTIC DORSAL NASAL SPLINTRichards Medical Co., Inc.K872905AMERICAN NASAL SPONGEAmerican Silk Sutures, Inc.K864932'EXMOOR' CAWOOD NASAL SPLINTSExmoor Plastics , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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